IEC 60601-1-12:20 14+A1:2020构成IEC 60601-1:医用电气设备-第1部分:基本安全和基本性能的一般要求以下简称为通用标准的附属标准。医疗实践越来越多地使用医疗电气设备和医疗电气系统来监测、治疗或诊断紧急医疗服务环境中的患者。在这种不受控制的恶劣环境中，医疗电气设备的安全性令人担忧。这一附带标准是在临床医生、工程师和监管机构的贡献下制定的。本附属标准的术语、要求、一般建议和指南旨在对医用电气设备和医用电气系统的制造商以及负责制定特定标准的技术委员会有用。本国际标准适用于医用电气设备和医用电气系统（以下简称ME设备和ME系统）的基本安全和基本性能，如其制造商的使用说明中所述，这些设备和医用电气系统旨在用于EMS环境（紧急医疗服务环境）。本附属标准的目的是为环境条件不同于室内条件的情况下，运送到紧急情况现场并在那里使用的ME设备和ME系统以及在运输中使用的ME设备和ME系统提供一般要求。本辅助标准的目的是规定除一般标准之外的一般要求，并作为特定标准的基础。该合并版本由第一版（2014年）及其修正案1（2020年）组成。因此，除本出版物外，无需下令修订。

IEC 60601-1-12:2014+A1:2020 constitutes a collateral standard to IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance hereafter referred to as the general standard. Medical practice is increasingly using medical electrical equipment and medical electrical systems for monitoring, treatment or diagnosis of patients in the emergency medical services environment. The safety of medical electrical equipment in this uncontrolled, rough environment is a cause for concern. This collateral standard was developed with contributions from clinicians, engineers and regulators. The terminology, requirements, general recommendations and guidance of this collateral standard are intended to be useful for manufacturers of medical electrical equipment and medical electrical systems and for technical committees responsible for the development of particular standards. This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems, which are intended, as indicated in the instructions for use by their manufacturer, for use in the EMS environment (Emergency Medical Services environment). The object of this collateral standard is to provide general requirements for ME equipment and ME systems carried to the scene of an emergency and used there, as well as in transport, in situations where the ambient conditions differ from indoor conditions. The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. This consolidated version consists of the first edition (2014) and its amendment 1 (2020). Therefore, no need to order amendment in addition to this publication.